MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

Catalog Number 1758SI16

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that water leaked from the foley catheter balloon during the pretest.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that water leaked from the foley catheter balloon during the pretest.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The residual risk region for this failure is low.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿imperfection in balloon due to process ".However, there was insufficient information to confirm this potential root cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use: (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients (1) patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) patients with known allergy to silver coated catheter [shape, configuration and principles] bardex® silver lubri-sil® foley catheter system consists of a syringe prefilled with sterile water and water-soluble lubricant. balloon catheter: silicone; silver coating this product is made with bacti-guard® silver alloy coating. product numbers, sizes etc.Relevant to this package insert are shown in package labeling.[intended use & effect- efficacy] this device is an indwelling catheter in the bladder for urinary drainage.The surface of catheter is coated first with a trace amount of metallic silver, and then with polyurethane onto that, to inhibit proliferation of bacteria that may adhere to the catheter.[directions for use] 1.Method of use the device is intended for single use only and is not reusable.1) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.2) lubricate the distal end of the catheter with water-soluble lubricant.3) insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.4) pull catheter to seat the balloon at the level of the bladder neck and secure placement.5) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water to drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.2.Precautions for use 1) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.2) when deflating balloon, do not aspirate with a syringe.3) when inserting catheter with a stylet, confirm that the stylet has reached the tip of the catheter, and make sure to keep the stylet in place inside the catheter during insertion.4) when inflating balloon with sterile water, use the sterile water of the prescribed capacity labeled on the valve.5) no substance except sterile water should be used to inflate the balloon.6) do not wipe catheter surface with organic solvents such as alcohol.7) do not aspirate urine through drainage funnel wall.8) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.Shaft 3 9) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.[precautions] 1.Precautions for use (exercise caution when using the device in the following patients) 1) exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.2.Important precautions 1) when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.2) if any possibility of retained balloon fragments exists, consider removing them using a cystoscope.3) when it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section ¿troubleshooting¿. when it is difficult to remove catheter by deflating the balloon (expressed as ¿removal-difficult case¿ hereinafter), take appropriate measures according to the following procedures.The following two methods are available for removal-difficult cases.A.Non-rupture method (sterile water is withdrawn without bursting the balloon.) b.Balloon-rupture method with balloon-rupture method, fragments of the ruptured balloon may remain in the bladder.Therefore, try non-rupture method first.3.Malfunction and adverse events 1) malfunction - catheter kinking, damage, rupture - difficulty or failure to remove the device - occlusion of catheter inner lumens - encrustation - accidental removal of the device due to leakage of sterile water or balloon rupture - device damage due to inappropriate use 2) adverse events - urinary-tract infection - hemorrhage, hematuria - allergy reaction to the device - calculus formation - edema - pain - discomfort - injury of bladder or urethral - urethritis, urinary incontinence - retained balloon fragments [storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box.".Correction: d, h.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18885729
• MDR Text Key: 337435091
• Report Number: 1018233-2024-01270
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1758SI16
• Device Lot Number: MYHV1872
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other